今天是:2020-08-05 星期三

Automated Laparoscopic Colorectal Surgery Workflow Recognition using Artificial Intelligence: Experimental Research
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注册号:

Registration number:

ChiCTR2000030488 

最近更新日期:

Date of Last Refreshed on:

2020-03-04 

注册时间:

Date of Registration:

2020-03-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Automated Laparoscopic Colorectal Surgery Workflow Recognition using Artificial Intelligence: Experimental Research 

Public title:

Automated Laparoscopic Colorectal Surgery Workflow Recognition using Artificial Intelligence: Experimental Research 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Automated Laparoscopic Colorectal Surgery Workflow Recognition using Artificial Intelligence: Experimental Research 

Scientific title:

Automated Laparoscopic Colorectal Surgery Workflow Recognition using Artificial Intelligence: Experimental Research 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

Daichi Kitaguchi 

研究负责人:

Nobuyoshi Takeshita 

Applicant:

Daichi Kitaguchi 

Study leader:

Nobuyoshi Takeshita 

申请注册联系人电话:

Applicant telephone:

+81-4-7133-1111 

研究负责人电话:

Study leader's telephone:

+81-4-7133-1111 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

dkitaguc@east.ncc.go.jp 

研究负责人电子邮件:

Study leader's E-mail:

ntakeshi@east.ncc.go.jp 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan 

研究负责人通讯地址:

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan 

Applicant address:

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan 

Study leader's address:

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan 

申请注册联系人邮政编码:

Applicant postcode:

277-8577 

研究负责人邮政编码:

Study leader's postcode:

277-8577 

申请人所在单位:

日本国家癌症中心东医院 

Applicant's institution:

National Cancer Center Hospital East 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017-419 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

The institutional review board (IRB) of the National Cancer Center Hospital East 

Name of the ethic committee:

The institutional review board (IRB) of the National Cancer Center Hospital East 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-02-22 

伦理委员会联系人:

The institutional review board (IRB) of the National Cancer Center Hospital East 

Contact Name of the ethic committee:

The institutional review board (IRB) of the National Cancer Center Hospital East 

伦理委员会联系地址:

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan 

Contact Address of the ethic committee:

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

Masaaki Ito 

Primary sponsor:

Masaaki Ito 

研究实施负责(组长)单位地址:

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan 

Primary sponsor's address:

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

日本

省(直辖市):

Chiba

市(区县):

Kashiwa

Country:

Japan

Province:

Chiba

City:

Kashiwa

单位(医院):

日本国家癌症中心东医院

具体地址:

6-5-1, Kashiwanoha

Institution
hospital:

National Cancer Center Hospital East

Address:

6-5-1, Kashiwanoha

经费或物资来源:

The Japan Agency for Medical Research and Development (AMED) 

Source(s) of funding:

The Japan Agency for Medical Research and Development (AMED) 

研究疾病:

结直肠癌 

Target disease:

Colorectal cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

This study aimed to construct a large annotated dataset comprising laparoscopic colorectal surgery (LCRS) videos from multiple institutions and evaluate the accuracy of automatic recognition for surgical phase, action, and tool by combining this dataset with AI. 

Objectives of Study:

This study aimed to construct a large annotated dataset comprising laparoscopic colorectal surgery (LCRS) videos from multiple institutions and evaluate the accuracy of automatic recognition for surgical phase, action, and tool by combining this dataset with AI. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

All patients underwent LCRS for colorectal cancer between 2009 and 2019. 

Inclusion criteria

All patients underwent LCRS for colorectal cancer between 2009 and 2019. 

排除标准:

None 

Exclusion criteria:

None 

研究实施时间:

Study execute time:

From2017-04-01To 2019-03-31 

征募观察对象时间:

Recruiting time:

From2009-04-01To 2019-03-31 

干预措施:

Interventions:

组别:

Single arm

样本量:

300

Group:

Single arm

Sample size:

干预措施:

None

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

日本 

省(直辖市):

Chiba 

市(区县):

 

Country:

Japan 

Province:

Chiba 

City:

 

单位(医院):

日本国家癌症中心东医院 

单位级别:

 

Institution
hospital:

National Cancer Center Hospital East  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

Overall accuracy

指标类型:

主要指标 

Outcome:

Overall accuracy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Mean intersection over union (mIoU)

指标类型:

主要指标 

Outcome:

Mean intersection over union (mIoU)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 31 years
最大 Max age 93 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The data will be made available on request.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The data will be made available on request.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

CRF

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-04
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